Patient-Reported Lupus Flare Symptoms Are Associated with Worsened Patient Outcomes and Increased Economic Burden

Katz, Patricia P.; Nelson, Winnie W.; Daly, R Paola; Topf, Lauren; Connolly-Strong, Erin; Reed, Michael L.

doi:10.18553/jmcp.2020.26.3.275

Cited by 19 publications

(28 citation statements)

References 19 publications

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“…18 19 In 2010, 4 69.5% reported that lupus had affected their career versus 65.8% in 2020; of those, 29.4% reported the need to work flexible hours in 2010 versus 31.9% in 2020. Similar results have been shown in large US studies, [20][21][22] also showing a relationship between disease activity and work productivity loss, as well as with activity impairment. This yielded generally high levels of anxiety about the future in this survey.…”

Section: Impact Of Sle On Studies Work and Family Lifesupporting

confidence: 89%

Living with systemic lupus erythematosus in 2020: a European patient survey

Cornet¹,

Andersen²,

Myllys³

et al. 2021

Lupus Sci Med

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ObjectiveThe aim of this study was to analyse the 2020 burden of Systemic Lupus Erythematosus (SLE) in Europe, from the patients’ perspective.MethodsIn May 2020, Lupus Europe, the European umbrella patient association for SLE, designed and disseminated a multilingual anonymous online survey to individuals with a self-reported physician’s diagnosis of SLE living in Europe.ResultsData from 4375 SLE survey respondents (95.9% women, median age: 45 (IQR: 36–54) years, 70.7% Caucasians) from 35 European countries were analysed. The median age at SLE diagnosis was 30 years (IQR: 22–40) and the median diagnosis delay was 2 years (IQR: 0–6). The most commonly affected organ-systems included the joints (81.8%) and skin (59.4%), with renal involvement in 30%. Another diagnosis was given before that of SLE in 45.0%, including psychological/mental disorders in 9.1% and fibromyalgia in 5.9%. The median number of symptoms reported was 9 (IQR: 6–11) out of 21, with fatigue most common (85.3%) and most bothersome. The median number of SLE-related medications was 5 (IQR: 3–7), including antimalarials (75%), oral glucocorticoids (52.4%), immunosuppressants (39.8%) and biologics (10.9%). Respondents reported significant impact over their studies, career and emotional/sexual life in 50.7%, 57.9% and 38.2%, respectively. Appropriate access to care was highly variable across countries and care component.ConclusionThis survey underlines the 2020 burden and strong heterogeneity in the care of SLE across Europe, from the patient’s perspective. Altogether, these data may prove crucial to physicians, patients and policy-makers to improve the diagnosis and management of this rare and complex disease.

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Section: Impact Of Sle On Studies Work and Family Lifesupporting

confidence: 89%

Living with systemic lupus erythematosus in 2020: a European patient survey

Cornet¹,

Andersen²,

Myllys³

et al. 2021

Lupus Sci Med

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“…As well as contributing to organ damage, flares can also significantly impact health-related quality of life and place an economic burden on patients with SLE. 29,30 Increased flare frequency is associated with lower scores in general health and physical function, as assessed using the Medical Outcome Short Form 36 Health Survey. 31,32 Specifically, musculoskeletal flares have been independently associated with bodily pain and decreased physical function, social function, and physical health.…”

Section: Discussionmentioning

confidence: 99%

“…SLE flare frequency is also associated with poor health outcomes as measured by increased hospitalizations, activity impairment, and work absenteeism with lowered work productivity. 29 In addition, health care costs directly relate to flare frequency and severity, with severe flares incurring greater costs than mild or moderate flares. 29,30,33,34 Flare prevention may therefore be predicted to reduce associated direct and indirect health care costs and to improve health-related quality of life for patients with SLE.…”

Section: Discussionmentioning

confidence: 99%

Anifrolumab reduces flare rates in patients with moderate to severe systemic lupus erythematosus

Furie

Morand

Askanase

et al. 2021

Lupus

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Background Systemic lupus erythematosus (SLE) management objectives include preventing disease flares while minimizing glucocorticoid exposure. Pooled data from the phase 3 TULIP-1 and TULIP-2 trials in patients with moderate to severe SLE were analyzed to determine anifrolumab’s effect on flares, including those arising with glucocorticoid taper. Methods TULIP-1 and TULIP-2 were randomized, placebo-controlled, 52-week trials of intravenous anifrolumab (300 mg every 4 weeks for 48 weeks). For patients receiving baseline glucocorticoid ≥10 mg/day, attempted taper to ≤7.5 mg/day prednisone or equivalent from Weeks 8–40 was required and defined as sustained reduction when maintained through Week 52. Flares were defined as ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B scores versus the previous visit. Flare assessments were compared for patients receiving anifrolumab versus placebo. Results Compared with placebo (n = 366), anifrolumab (n = 360) was associated with lower annualized flare rates (rate ratio 0.75, 95% confidence interval [CI] 0.60–0.95), prolonged time to first flare (hazard ratio 0.70, 95% CI 0.55–0.89), and fewer patients with ≥1 flare (difference −9.3%, 95% CI −16.3 to −2.3), as well as flares in organ domains commonly active at baseline (musculoskeletal, mucocutaneous). Fewer BILAG-based Composite Lupus Assessment responders had ≥1 flare with anifrolumab (21.1%, 36/171) versus placebo (30.4%, 34/112). Of patients who achieved sustained glucocorticoid reductions from ≥10 mg/day at baseline, more remained flare free with anifrolumab (40.0%, 76/190) versus placebo (17.3%, 32/185). Conclusions Analyses of pooled TULIP-1 and TULIP-2 data support that anifrolumab reduces flares while permitting glucocorticoid taper in patients with SLE. ClinicalTrials.gov identifiers TULIP-1 NCT02446912 (clinicaltrials.gov/ct2/show/NCT02446912); TULIP-2 NCT02446899 (clinicaltrials.gov/ct2/show/NCT02446899).

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“…In the long term, both disease flares and oral glucocorticoid use have been linked to organ damage, which itself increases mortality ( 22 , 23 , 24 , 25 , 26 ). Flares are also associated with reduced health‐related quality of life, and flare severity together with oral glucocorticoid use correlate with health care costs ( 27 , 28 , 29 , 30 , 31 ). A key SLE treatment goal therefore is to prevent flares while minimizing oral glucocorticoid exposure, which in turn is expected to reduce medical resource utilization ( 27 , 28 , 29 , 30 , 32 , 33 ).…”

Section: Discussionmentioning

confidence: 99%

What Does It Mean to Be a British Isles Lupus Assessment Group–Based Composite Lupus Assessment Responder? Post Hoc Analysis of Two Phase III Trials

Furie

Morand

Bruce

et al. 2021

Arthritis & Rheumatology

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Objective The British Isles Lupus Assessment Group–based Composite Lupus Assessment (BICLA) is a validated global measure of treatment response in systemic lupus erythematosus (SLE) clinical trials. To understand the relevance of BICLA in clinical practice, we investigated relationships between BICLA response and routine SLE assessments, patient‐reported outcomes (PROs), and medical resource utilization. Methods This was a post hoc analysis of pooled data from the phase III, randomized, placebo‐controlled, 52‐week TULIP‐1 (ClinicalTrials.gov identifier: NCT02446912; n = 457) and TULIP‐2 (ClinicalTrials.gov identifier: NCT02446899; n = 362) trials of intravenous anifrolumab (150/300 mg once every 4 weeks) in patients with moderate‐to‐severe SLE. Changes from baseline to week 52 in clinical assessments, PROs, and medical resource use were compared in BICLA responders versus nonresponders, regardless of treatment assignment. Results BICLA responders (n = 318) achieved significantly improved outcomes compared with nonresponders (n = 501), including lower flare rates, higher rates of attainment of sustained oral glucocorticoid taper to ≤7.5 mg/day, greater improvements in PROs (Functional Assessment of Chronic Illness Therapy–Fatigue, Short Form 36 Health Survey), and fewer SLE‐related hospitalizations/emergency department visits (all nominal P < 0.001). Compared with nonresponders, BICLA responders had greater improvements in global and organ‐specific disease activity (Physician’s Global Assessment, SLE Disease Activity Index 2000, Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity, and joint counts; all nominal P < 0.001). BICLA responders had fewer lupus‐related serious adverse events than nonresponders. Conclusion BICLA response is associated with clinical benefit in SLE assessments, PROs, and medical resource utilization, confirming its value as a clinical trial end point that is associated with measures important to patient care.

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Patient-Reported Lupus Flare Symptoms Are Associated with Worsened Patient Outcomes and Increased Economic Burden

Cited by 19 publications

References 19 publications

Living with systemic lupus erythematosus in 2020: a European patient survey

Living with systemic lupus erythematosus in 2020: a European patient survey

Anifrolumab reduces flare rates in patients with moderate to severe systemic lupus erythematosus

What Does It Mean to Be a British Isles Lupus Assessment Group–Based Composite Lupus Assessment Responder? Post Hoc Analysis of Two Phase III Trials

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